Agomelatine

Description

Agomelatine is used for the treatment of symptoms of depression. It may also be used to prevent the relapse of depression symptoms. This medicine helps in regulating the body clock (circadian rhythm) with positive benefits on mood and sleep in patients suffering from depression.

Side effects

Major & minor side effects for Agomelatine

  • Headache
  • Dizziness
  • Sleepiness
  • Nausea
  • Diarrhea
  • Constipation
  • Abdominal pain
  • Extreme tiredness
  • Agitation and anxiety
  • Abnormal dreams
  • Increase in liver enzyme levels
  • Weight gain
  • Migraine like headaches
  • Tingling or pricking sensation
  • Blurred vision
  • Restless legs
  • Ringing or buzzing in the ears
  • Severe skin rash and hives
  • Aggression or anger
  • Swelling of the face, arms, hands, lower legs, or feet
  • Yellowing of skin and eyes
  • Hallucinations
  • Inability to empty the bladder

Uses of Agomelatine

What is it prescribed for?

  • Major depression
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Concerns

Commonly asked questions

  • Onset of action
    The amount of time taken by this medicine to show its effect is not clinically established.
  • Duration of effect
    The amount of time for which this medicine remains effective in the body is not clinically determined.
  • Safe with alcohol?
    Consumption of alcohol is not recommended during treatment with this medicine due to the increased risk of severe adverse effects including liver damage. It is advised that you do not perform any activities that require high mental alertness such as driving a vehicle or operating machinery if you consume alcohol during treatment with this medicine.
  • Is it habit forming?
    No habit-forming tendencies were reported.
  • Usage in pregnancy?
    This medicine is not recommended for use in pregnant women unless absolutely necessary. Your doctor will determine the best course of treatment after evaluating the potential risks and benefits associated with the use of this medicine.
  • Usage while breast-feeding?
    This medicine is not recommended for use in breastfeeding women unless absolutely necessary. All the risks and benefits should be discussed with the doctor before taking this medicine. Your doctor may advise you to discontinue breastfeeding or to discontinue the drug based on your clinical condition.

Allergy

This medicine is not recommended for use in patients with a known allergy to agomelatine or any other inactive ingredients present along with it.

Hepatic impairment

This medicine is not recommended for use in patients with active liver diseases and patients whose transaminase levels are more than 3 times the upper limit of normal due to the increased risk of worsening of the patient’s condition.

CYP1A2 inhibitors

This medicine is not recommended for use in patients who are concomitantly taking strong CYP1A2 inhibitors such as fluvoxamine, ciprofloxacin, etc. due to the increased risk of worsening of the patient’s condition.
Warnings for special population

Pregnancy

This medicine is not recommended for use in pregnant women unless absolutely necessary. Your doctor will determine the best course of treatment after evaluating the potential risks and benefits associated with the use of this medicine.

Breast-feeding

This medicine is not recommended for use in breastfeeding women unless absolutely necessary. All the risks and benefits should be discussed with the doctor before taking this medicine. Your doctor may advise you to discontinue breastfeeding or to discontinue the drug based on your clinical condition.
General warnings

Other medicines

Agomelatine may interact with many other medicines and may cause severe adverse effects. Hence, it is advised that you inform the doctor about all your current medicines including any herbs and supplements before beginning treatment with this medicine.

Risk of liver damage

This medicine should be used with caution in patients who are at risk of liver injuries such as diabetic patients, obese or overweight patients, etc. due to the increased risk of liver damage. Regular assessment of liver function is necessary before initiating the therapy with this medicine and during the therapy. Replacement with a suitable alternative may be necessary in some cases based on the clinical condition of the patient.

Use in children

This medicine is not recommended for use in patients less than 18 years of age since the safety and efficacy of use are not clinically established.

Use in elderly

This medicine is not recommended for use in patients greater than 65 years of age since the safety and efficacy of use are not clinically established.

Bipolar disorder

This medicine should be used with caution in patients with bipolar disorder due to the increased risk of worsening of the patient's condition. Therapy should be discontinued if the manic symptoms recur or become severe.

Dementia

This medicine should be used with extreme caution in patients with dementia due to the increased risk of worsening of the patient's condition. Use of this medicine is not recommended in elderly patients suffering from dementia.

Suicidal ideation

This medicine should be used with extreme caution due to the increased risk of suicidal tendencies. Patients should be closely monitored for any change in mood or behavior. Appropriate dose adjustments or replacement with a suitable alternative may be necessary based on the clinical condition.

Smoking

Excessive smoking ( especially >= 15 cigarettes per day) decreases the effectiveness of Agomelatine. Hence, it is advised to avoid smoking during therapy with this medicine. If discontinuation of smoking is not possible, appropriate dose adjustments or replacement with a suitable alternative may be required based on the clinical condition and therapeutic response.

Driving or Operating machinery

Use of this medicine may cause adverse effects such as dizziness, blurred vision, sleepiness, etc. in some patients. It is advised that you do not perform any activities such as driving a vehicle or operating machinery if you experience any of these symptoms during treatment with this medicine.

Missed Dose

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose. Do not double your dose to make up for the missed one.

Overdose

Seek emergency medical treatment or contact the doctor in case of an overdose.
All drugs interact differently for person to person. You should check all the possible interactions with your doctor before starting any medicine.
Interaction with Alcohol

Description

N/A

Instructions

Consumption of alcohol is not recommended during treatment with this medicine due to the increased risk of severe adverse effects including liver damage. It is advised that you do not perform any activities that require high mental alertness such as driving a vehicle or operating machinery if you consume alcohol during treatment with this medicine.
Interaction with Medicine

Propranolol

Ciprofloxacin

Estrogens

Rifampicin

Fluvoxamine

Enoxacin

Disease interactions

Dementia

This medicine should be used with extreme caution in patients suffering from dementia due to the increased risk of severe adverse effects. This medicine is not recommended for use in elderly patients with dementia. Close monitoring of clinical condition, appropriate dose adjustments, or replacement with a suitable alternative may be necessary in some cases based on the patient's condition.

Bipolar disorder

This medicine should be used with extreme caution in patients with a known history of bipolar disorder or mania due to the increased risk of severe adverse effects. It is advised to discontinue this medicine if the patient develops any symptoms of mania or bipolar disorder. Close monitoring of clinical condition, appropriate dose adjustments, or replacement with a suitable alternative may be necessary in some cases based on the patient's condition.
Food interactions
Information not available.
Lab interactions
Information not available.
Take this medicine exactly as prescribed by the doctor. Do not take in larger or smaller quantities than prescribed. Contact your doctor if symptoms do not improve after a week of therapy with this medicine. You may need to undergo liver function tests before and during therapy with this medicine. Report any adverse effects such as yellowing of skin or eyes, unusual tiredness, light-colored stools, etc. to the doctor immediately. Ensure that the course of treatment is completed. Do not stop the use of this medicine without consulting your doctor.
Miscelleneous

Can be taken with or without food, as advised by your doctor

To be taken at bedtime only

May cause sleepiness

How it works
This medicine works by altering the levels of certain chemicals in the brain which helps in treating the symptoms of depression.
Legal Status

Approved

Unknown

Unknown

Approved

Classification

Category

Antidepressants

Schedule

Schedule H

Agomelatine - DrugBank [Internet]. Drugbank.ca. 2018 [cited 21 August 2018]. Available from:

https://www.drugbank.ca/drugs/DB06594

[Internet]. Medicines.org.au. 2018 [cited 21 August 2018]. Available from:

http://www.medicines.org.au/files/sepvaldx.pdf

[Internet]. Ema.europa.eu. 2018 [cited 21 August 2018]. Available from:

http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000915/WC500046227.pdf

[Internet]. Medicines.org.uk. 2018 [cited 21 August 2018]. Available from:

https://www.medicines.org.uk/emc/files/pil.6564.pdf

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Information on this page was last updated on 28 Dec 2018

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